Cartesian Therapeutics (NASDAQ:RNAC) provided an update on its Descartes-08 program, a first-in-class autologous mRNA-engineered CAR-T cell therapy targeting B-cell maturation antigen (BCMA) for the treatment of autoimmune diseases, and outlined key 2026 priorities.
Enrollment remains on track in the randomized, double-blind Phase 3 AURORA trial evaluating Descartes-08 in approximately 100 participants with acetylcholine receptor antibody-positive (AChR Ab+) myasthenia gravis (MG).
The study administers six once-weekly outpatient infusions without the need for lymphodepleting preconditioning chemotherapy.
The primary endpoint is a ≥3-point improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Month 4.
The U.S. Food and Drug Administration has accepted an Investigational New Drug application for the seamless adaptive Phase 2 TRITON trial of Descartes-08 in myositis.
The study is designed to enroll up to 50 participants, incorporating an interim analysis after the first 10 patients to inform the potential for a single pivotal trial.
The company anticipates initiating this trial in the first half of 2026.
Additionally, Cartesian has initiated the Phase 1/2 HELIOS trial evaluating Descartes-08 in pediatric patients with juvenile dermatomyositis, further expanding the program's footprint across autoimmune indications.